EN 980:1996
(Main)Graphical symbols for use in the labelling of medical devices
Graphical symbols for use in the labelling of medical devices
This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices. Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Diese europäische Norm legt die graphischen Symbole fest, die von den Herstellern für Informationen zu Medizinprodukten, wie sie in den EG-Richtlinien über Medizinprodukte, aktive implantierbare Medizinprodukte und In-vitro-Diagnostika (in Vorbereitung) definiert sind, verwendet werden sollten.
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
La présente norme européenne spécifie les symboles graphiques destinés à être inclus dans les informations fournies par le fabricant avec les dispositifs médicaux, tels que définis dans les Directives de la CEE relatives aux dispositifs médicaux, aux dispositifs médicaux implantables actifs et aux dispositifs médicaux de diagnostic in vitro (en cours d'élaboration).
Grafični simboli za označevanje medicinskih pripomočkov
General Information
- Status
- Withdrawn
- Publication Date
- 21-May-1996
- Withdrawal Date
- 15-Apr-2003
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 16-Apr-2003
- Completion Date
- 16-Apr-2003
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 10-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
Get Certified
Connect with accredited certification bodies for this standard

BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.

TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 980:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Graphical symbols for use in the labelling of medical devices". This standard covers: This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices. Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.
This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices. Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.
EN 980:1996 is classified under the following ICS (International Classification for Standards) categories: 01.080.20 - Graphical symbols for use on specific equipment; 11.040.01 - Medical equipment in general; 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 980:1996 has the following relationships with other standards: It is inter standard links to EN 980:2003, EN 45502-1:1997, EN 12838:2000, EN 980:1996/A1:1999, EN 980:1996/A2:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 980:1996 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/252, M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 980:1996 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
*UDILþQLVLPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
Graphical symbols for use in the labelling of medical devices
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
Ta slovenski standard je istoveten z: EN 980:1996
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.120.01 Farmacija na splošno Pharmaceutics in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN
...




Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...